| ObjectiveThis preliminary research intends to verify the feasibility of the randomized,double-blind,placebo-controlled experiment design with three arms;to explore the efficacy difference and safety of Yinxieling tablet,PSORI-CMO2 and placebo;and to look for the possible therapeutic mechanism of PSORI-CMO2 from the angle of immune cells.MethodsThis pilot study adopts randomized,double-blind,placebo-controlled experiment method.120 eligible cases from Guangdong provincial hospital and Beijing university of Chinese medicine Dongzhimen affiliated hospital were randomly divided into Group A(Yinxieling tablet + PSORI-CM02 particle placebo),Group B(PSORI-CM02 particle + Yinxieling tablet placebo)and Group C(PSORI-CM02 particle placebo + Yinxieling tablet placebo),and each group got 40 cases.After 12 weeks of treatments and 12 weeks of follow-ups,we compared the outcome measures.The Main outcome indicator was the improvement rate of PASI score.The secondary outcome indicators included the reach rate of PASI-50,the reach rate of PASI-75,visual analog scale(VAS),body surface area(BSA),dermatology life quality index(DLQI),Skindex29,the recurrence rate,the rebound rate and the effective time.Before and after treatments,all patients were required biological samples about anticoagulant blood.When the study was over,we selected 10 patients with the best curative effect and 12 patients with the worst curative effect from group B,according to the difference of PASI score before and after treatments.The blood samples came to 44 cases.At the same time,recruit 8 cases of healthy people whose age,sex matched.Meanwhile,take their blood samples as healthy controls.CD4+,CD8+,CD56+,and CD4+ROR ? t were detected by BD FACSAria III flow flow cytometry.Results1.In terms of therapeutic effect:(1)Group A got the highest improvement rate of PASI score at both week 12 and week 24.However,there was no statistically significant difference between the three groups.(2)There was no statistically significant difference between the three groups on the reach rate of PASI-50?the reach rate of PASI-75?VAS scores?BSA scores and the effective time at any time point.And there was no statistically significant difference between the three groups on the VAS difference and the BSA difference before and after treatments at both week 12 and week 24.(3)According to the trend chart of DLQI scores at any time,it can be seen that group B got the lowest score and the best life quality.There was no statistically significant difference between the three groups.It can be seen from the comparison of DLQI scores that there was no statistically significant difference between the three groups at any time point.(4)The scores of the three dimensions of Skindex 29 decreased at all time points.Group B fell the most obvious,scored lowest,showed best life quality.However,there was no statistically significant difference between the three groups.It can be seen from the comparison between groups at the three dimensions that there was no statistically significant difference between the three groups at any time point.According to the above results,Yinxieling tablet and PSORI-CMO2 have potential advantages on improving the PASI scores and the life quality when compared with placebo.However,due to the insufficient sample size of the pilot study,the purpose of which was to explore its feasibility with a preliminary evaluation of efficacy and safety,the differences between the three groups were needed to be further verified through the expansion of the sample size.2.In the aspects of the recurrence rate and rebound rate:(1)After 6 weeks of treatments,the first recurrence occurred in group C,meanwhile no recurrence occurred in group A and group B.The first recurrence of group B occurred at the 10 th week,and the first recurrence of group A occurred at the 16 th week.(2)However,there was no statistically significant difference on the recurrence rate and rebound rate between the three groups at any time point.According to the above results,Yinxieling tablet and PSORI-CMO2 have potential advantages on delaying the recurrence of psoriasis when compared with placebo.However,due to the insufficient sample size of the pilot study,the purpose of which was to explore its feasibility with a preliminary evaluation of efficacy and safety,the differences between the three groups were needed to be further verified through the expansion of the sample size.3.In terms of security:(1)A total of 86 cases of adverse events took place in this study,of which the highest frequency were infections and infection diseases,followed by gastrointestinal system disease,according to MedDRA20.0 system organs classification.The rate of adverse events of Group A was the lowest.There was no statistically significant difference between the three groups.(2)During the whole study,Group A and Group B respectively got one adverse reaction,both of which were diarrhea.There was no statistically significant difference between the three groups.According to the above results,Yinxieling tablet and PSORI-CMO2 are relatively safe.4.In the aspects of biological sample test results:(1)The 22 patients were compared with the healthy controls both before and after the treatments,and the results showed that there was no statistical difference between them on the CD4 +,CD8 + and CD4+ROR?t + positive cells.However,the CD56 + positive cells amount of the psoriatic patients was obviously higher than the control group both before and after the treatments,which hinted that NK cells might play an important role in the development of psoriasis.(2)According to the difference of PASI score before and after treatments to find 10 cases with good effect in group B and compare them with the control group both before and after the treatments,we found that there was no statistical difference between them on the CD4 +,CD8 + and CD4+ROR ? t + positive cells.However,the CD56 + positive cells amount of the psoriatic patients was obviously higher than the control group before the treatments while after the treatments there was no statistical difference between them,which suggested that the NK cells of the patients with good effect in group B decreased and tended to the healthy control level after the treatment with PSORI-CM02.(3)The amount of the NK cells of the patients wtth good effect in Group B was on decline while those with bad effect were unchanged or even higher,whiched meaned that PSORI-CM02 might take effect through the immune response of NK cells in patients with psoriasis.Conclusions1.According to the results of clinical research,Yinxieling tablet,PSORI-CMO2 are relatively safe and have potential advantages on improving the PASI scores,improving the life quality and delaying the recurrence of psoriasis when compared with placebo.However,due to the insufficient sample size of the pilot study,the purpose of which was to explore its feasibility with a preliminary evaluation of efficacy and safety,the differences between the three groups were needed to be further verified through the expansion of the sample size.2.According to the results of experiment research,NK cells play an important role in the development of psoriasis.After the treatment with PSORI-CM02,the NK cells in the patients with good effect decreased and tended to the healthy control level.PSORI-CM02 might take effect through the immune response of NK cells in patients with psoriasis.3.The study process is smooth,which shows the strong feasibility of conducting a large sample randomized double-blind controlled trial.The results of the study will provide a basis for the calculation of the sample size and the revision of the future research plan. |
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